| Scientific Title of Trial | The effect of music: on selected aspects of cardio respiratory physiology of asymptomatic individuals and on selected aspects of the clinical profile and the quality of life of chronic stable angina patients | |
| Public Title of Trial (in lay language) | The effect of music: on cardio respiratory physiology of asymptomatic individuals and the effect of music on the disease condition and the quality of life in patients heart disease [stable angina patients] | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
None | |
| Disease or Health Condition(s) studied | Cardio respiratory physiology and chronic stable angina | |
| What is the research question being addressed? | The effect of music on human physiology ? | |
| Study design | Study 1 Community based experimental study Study 2 Randomised controlled trial (Clinical trial) | |
| Intervention(s) planned | Listening to a piece of music for 20 minutes Study 2 Listening to a piece of music twice a day for 20 minutes each for one month | |
| Inclusion criteria | Study 1 Both male and female individuals between 45 to 65 years of age The individuals who are not having heart disease and hypertension and who are not being on any long term treatment The individuals whose pulse rate, blood pressure and heart sounds are within normal range The individuals who don’t have hearing impairment Study 2 Clinically diagnosed chronic stable angina patients confirmed by exercise ECG using bruce protocol during the study period Patients with no other heart diseases Both male and female patients between 45 to 65 years of age Patients whose clinical condition is stable and who do not require frequent change of the treatment Patients who can perform exercise ECG test Patients who like to participate in the study | |
| Exclusion criteria | Study 1 •Both male and female individuals less than 45 years of age and more than 65 years of age •Individuals who are being on long-term treatment for any disease •The individuals whose pulse rate, blood pressure and heart sounds are not within normal range •The individuals who have hearing impairment Study2 •Previously diagnosed patients with chronic stable angina •Clinically diagnosed chronic stable angina patients •confirmed by exercise ECG using Modified Bruce protocol during the study period •Patients with other heart diseases •Patients with heart failure •Patients who are being on treatment for Hypertension and Diabetes Mellitus •Patients who are less than 45 years of age and more than 65 years of age •Patients whose clinical condition is not stable and who change their treatment frequently •Patients who cannot perform exercise ECG such as disabled patients •Patients who do not like to participate in the study | |
| Target number / sample size | Study 1 - 532 subjects Study 2 - 66 subjects | |
| Primary outcome(s) | Study 1 Changes in Diastolic Blood pressure Study 2 The time taken to 1 mm ST segment depression in exercise ECG | |
| Primary outcome(s) - time of assessment(s) | ||
| Secondary outcome(s) | Study 1 •Blood pressure •Pulse rate •Respiratory rate Study 2 •Clinical Profile: State of Ischemia •Exercise duration (s) •Stage at which patient stops the test •Maximal heart rate during exercise (beats. Min-1) •Time until 1 mm ST segment depression •Maximal ST segment depression •Double product (Heart rate/min X Blood pressure mmHg) •Symptom of ischemia •Quality of life | |
| Secondary outcome(s) - time of assessment(s) | ||
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 02/01/2007 | |
| Anticipated end date | 31/12/2007 | |
| Recruitment status | Completed | |
| State of ethics review approval | Approved by the Ethical Review Committee , University of Sri Jayewardenapura | |
| Funding source(s) | Not yet found | |
| Applicant's Email | sssiritunga@yahoo.com | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | Dr. T.L.S.S.Siritunga
Medical Officer (Trainee - MD Community Medicine) 56/1, Morontuduwa Road, Wadduwa 038-2233072 , 077-9664127 sssiritunga@yahoo.com |
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| Primary Study Sponsor/ Organization | None
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| Contact Person for Public Queries | Dr. T.L.S.S.Siritunga Medical Officer (Trainee - MD Community Medicine) 56/1, Morontuduwa Road, Wadduwa 038-2233072, 077-9664127 sssiritunga@yahoo.com |
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| Secondary Study Sponsor(s), (if any) | None |
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